The delivery of medicament through a person's skin utilizing electrophoresis and/or electro-osmosis is one where the drug molecules in solution or suspension are made subject to an electric field, and in the case of electrophoresis, if the electrode having the same charge as that of the ionic molecules is above the solution adjacent the skin which is the site of administration, the ions will be repelled and migrate through the skin into the blood stream; whereas in the case of electro-osmosis, a solution of water is attracted to the negative electrode, and thus any electric current flowing through a porous membrane causes a flow therethrough. Such electrochemical processes, although similar in end result do, however, function together, but separately or independently, in pumping and/or delivering a drug or other medication transdermally.
U.S. Pat. No. 3,547,107 to Chapman et al shows a self-contained chest mounted heart tachycardia detector, and an insertable replaceable battery is disclosed, and the device is held to the patient by a separate piece of tape.
U.S. Pat. No. 4,008,721 to Burton discloses a tape electrode per se for transmitting electrical signals through the skin. A silver metal containing electrically conductive layer is disposed over an adhesive layer.
In U.S. Pat. No. 4,325,367 to Tapper, there is disclosed a iontrophoretic treatment device which is self-contained in a fixed structural housing. Metal electrodes, particularly a stainless steel cathode and an aluminum anode are connected to respective adjacently mounted porous moisture absorbent pads, and are wire-connected to a battery. The device is not adhered to the user's body, but rather the user physically holds the device in place against the body.
U.S. Pat. No. 4,419,091 to Behl et al discloses an ion treatment electrode per se having a porous polymer substance with a conductive coating.
U.S. Pat. No. 3,163,166 to Brant et al discloses an iontophoresis device in a fixed interfitting structural housing, which is designed to be hand held in operation.
U.S. Pat. No. 2,493,155 to McMillan discloses an iontophoretic device which is strapped or taped to the body. The device is electrically operatively connected to an external controlled circuit source.
U.S. Pat. No. 4,239,046 to Ong is directed to an iontophoretic electrode construction per se including electrically conductive respective hook and knitted filaments for attachably detachable electrode connection.
U.S. Pat. No. 4,273,135 to Larimore et al is directed to a biomedical electrode per se in which the conductive material is formed of a cohesive, conformable, non-ionic hydrophilic synthetic polymer, so as to provide an essentially dry electrode.
U.S. Pat. No. 4,243,052 to Bailey is directed to a disposable electrode per se which combines a fabric backing and a conductive mesh layer laminated thereto, and a conductive polymer adhesive which interfaces the conductive mesh and which contacts the skin of the patient.
Also, U.S. Pat. No. 4,367,745 to Welage relates to an electrically polymeric conductive composition per se for interfacing between the skin and the electrode plate of a biomedical electrode.
None of the above-referenced devices disclose an electrophoretic and/or electro-osmosis bandage or applicator for the non-invasive transcutaneous delivery of a medicament which is a self-contained, self-adhering unit, in which the combination of elements including battery, a current regulating source, a medicament solution or reservoir, and an adhesive conductive lip are integrally connected by means of a flexible polymeric electrically conductive cover. Additionally, there is no teaching of an applicator or bandage-like transdermal drug delivery system in which specialized structural configurations compensate for one's movement and skin stretch so as to preclude loosening or "hot spots", or of incorporating a third or feedback electrode in the patch or applicator for regulating the drug dosage.
Other problems with such prior art devices were that they were bulky and lacked the necessary drug delivery rate control.
Another significant problem associated with such prior art devices is that the user, in wearing the device over the course of a few days caused the applicator patch to fall off because of one's movement during the day or by showering, perspiration, etc. These prior art devices did not provide for any structures which compensated for one's body movement, nor did they preclude the "peeling" effect. Moreover, no control means was provided for the regulation of administering the drug.